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PageInformation for sponsors and manufacturers explaining what to do if there is a medicine shortage.
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PageFind out how to manage a medical device supply disruption or shortage.
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PageDeficiencies or defects of medicines thought to have arisen during manufacture, storage or handling.
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PageCheck current information for sponsors and manufacturers about specific or ongoing safety issues.
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PageFind out about the Medical Devices Vigilance Program (MDVP) pilot, which aims to support Australian medical device sponsors to comply with their post-market vigilance responsibilities.
Latest alerts
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Safety alertsWe have become aware of an increasing number of cases of liver injury reported in scientific literature, by consumers who had taken products containing Garcinia gummi-gutta.
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Safety alertsThe TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna).
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Recall actionsBe alert to the issue of unexpected shut down of the A30 and A40 series bi-level positive airway pressure (BiPAP) devices. This can cause interruptions and loss of therapy for patients.
Latest articles
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TGA's decision to not register lecanemab (LEQEMBI)
NewsTGA has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease). -
Nitrosamine impurities acceptable intakes update - October 2024
NewsThe TGA is updating information for nitrosamine impurities in medicines including acceptable intakes (AI). -
Our response to questions asked about the Essential Principles consultation
NewsFollowing our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.
Latest publications
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Scheduling decisions (final)This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
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PublicationsFind out about the seasonal influenza vaccines available for the 2024 southern hemisphere season.
Resources
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q10; EMA/CHMP/ICH/214732/
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q8, Q9 & Q10 Q&As (volume 4); EMA/CHMP/ICH/265145/2009
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User guideStep by step guide to submitting a Custom-Made Medical Device (CMMD) notification.
Latest consultations
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ConsultationThis consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
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ConsultationThe TGA is seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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ConsultationHave your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.